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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Electrode Recording, Or Probe, Electrode Recording
510(k) Number K894500
Device Name DAIG ELECTROPHYSIOLOGY CATHETER
Applicant
Daig Corp.
14901 Deveau Pl.
Minnetonka,  MN  55345
Applicant Contact J FLEISCHHACKER
Correspondent
Daig Corp.
14901 Deveau Pl.
Minnetonka,  MN  55345
Correspondent Contact J FLEISCHHACKER
Regulation Number870.1220
Classification Product Code
DRF  
Date Received07/19/1989
Decision Date 09/18/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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